Identity
- Trade Name
- Apollo FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- MICRO CATH 105-5095-000 V08 APOLLO 1.5CM FDA UDI
- Model / Reference
- 105-5095-000 FDA UDI
- Description
- MICRO CATH 105-5095-000 V08 APOLLO 1.5CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000446741 FDA UDI
- PMA Number
- P030004 FDA UDI
- FDA Product Code
- MFE FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Vascular microcatheter
Apollo by Micro Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular microcatheter.
- Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
- Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
- Merit Pursue™ — Merit Medical Systems, Inc. · Class I
- Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
- PROWLER — Medos International Sàrl · Class II
- Merit Maestro® — Merit Medical Systems, Inc. · Class II
- Lantern Delivery Catheter — PENUMBRA, INC. · Class II
- Direxion™ Fathom™-16 System — Boston Scientific · Class II
Cleared under the same submission
P030004 also covers:
- Apollo — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- Apollo Onyx — Micro Therapeutics, Inc.
- ApolloTM — Micro Therapeutics, Inc.
- ApolloTM — Micro Therapeutics, Inc.
- ONYX 18 — Micro Therapeutics, Inc.
- ONYX 34 — Micro Therapeutics, Inc.
- Onyx 18 — Micro Therapeutics, Inc.
- Onyx 34 — Micro Therapeutics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI bfec5268-93d9-492c-be30-8bc30fcf9d6c 36 fields · synced May 30, 2026